pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. Keep it simple.

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Clinical Trials Clinical Trials Trials Clinical Research 109

pharmaphorum

JANUARY 18, 2021

The need for diversity in clinical trial populations has been a topic of discussion across regulators and the industry in general for decades.

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Clinical Trials Clinical Trials Trials Drug Trials 52

FDA Law Blog

MAY 3, 2021

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). 42 C.F.R. §§ 11.10, 11.44(a).

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Clinical Trials Clinical Trials Trials Regulation 52

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

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Clinical Trials Clinical Trials Trials Production 52

Drug Discovery World

FEBRUARY 20, 2023

Results from the PROVENT Phase III trial showed a significant reduction in the risk of developing symptomatic Covid-19 and that the protection continued for at least six months. Prostate cancer A new metastatic prostate cancer drug was approved by the FDA in March, followed by the European Commission in December.

Drug Trials 52

Drug Trials Trials Clinical Trials Clinical Trials 52

FDA Law Blog

MAY 3, 2021

for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). 42 C.F.R. §§ 11.10, 11.44(a).

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Clinical Trials Clinical Trials Trials Regulation 40

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. Given the success of Oxford’s Phase II trial, the study investigators are now gearing up for a Phase III licensure trial to assess large-scale safety and efficacy in 4,800 children aged 5 to 36 months across four countries in Africa. Changing the Face of Malaria.

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Vaccination Vaccine Immune Response Trials 105

The Pharma Data

AUGUST 16, 2020

The Medical School Council (led by the heads of UK medical schools) and the regulator, the General Medical Council, say they are putting plans in place to improve the situation. Hundreds of other UK medical students have signed petitions demanding teaching that better reflects the diversity of the country. Life-or-death signs.

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Doctors Doctor Medicine Drug Trials 52

Delveinsight

AUGUST 12, 2021

LQTT has a portfolio of in-licensed compounds from Sanofi that prohibit serum/glucocorticoid-regulated kinase 1, or SGK1. That kinase plays a role in inappropriate sodium regulation, a hallmark of arrhythmias like Long QT Syndrome. Takeda leads Finch-partnered Microbiome IBD drug.

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Trials Clinical Trials Clinical Trials Regulation 97

Placebo Control

JULY 31, 2013

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “ fake fix ” that was being thoroughly “ignored” by the pharmaceutical industry. Pharma: breaking the law in broad daylight?

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Pharma Companies Trials Compliance Clinical Trials 40

The Pharma Data

MAY 17, 2021

Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). Clinical trial strategies for rare neurodevelopmental disorders: challenges and opportunities ( Nature ). Now they fear an increase.

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Trials Vaccination Vaccine Scientist 52